Ulcerative Colitis (UC)Phase 2ASCENTRA-UCNCT07845487

A Trial to Investigate PALI-2108 Versus Placebo in Participants With Moderately to Severely Active Ulcerative Colitis

A Phase 2 study testing PALI-2108 in people with Ulcerative Colitis (UC) and Severe Ulcerative Colitis, run by Palisade Bio at 115 sites in 12 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

The ASCENTRA-UC study is a phase 2 study testing PALI-2108 in patients with moderate to severe ulcerative colitis. Doses of drug will be compared against a placebo to see how well it works, how safe it is, and how the body responds to it. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Ulcerative Colitis (UC), Severe Ulcerative Colitis, Moderate Ulcerative Colitis
What is being tested?: PALI-2108
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 204 participants
Where: 115 sitesin 12 countries
Study dates: 28 Aug 2026to Jun 2028
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Documented clinical diagnosis of UC for ≥ 3 months prior to Screening. The diagnosis of UC must be confirmed by endoscopic and histologic evidence.
If a histopathology report is not available in the source records, a biopsy for a local histopathology evaluation (to obtain a report) can be obtained during the screening endoscopy procedure.
Moderately to severely active UC, defined as:
mMS of 5 to 9 (inclusive), AND
ES ≥ 2, AND
RB ≥ 1.

Show all 23Show fewer

Participants must satisfy at least one of the criteria listed under item a OR at least one of the criteria listed under item b:
History of inadequate response or loss of response, or intolerance to at least one prior UC therapy, defined as: i. Oral prednisone ≥ 40 mg/day (or equivalent) or budesonide ≥ 9 mg/day for ≥ 2 weeks.
Corticosteroid dependence: unable to taper < 10 mg/day prednisone equivalent within 3 months, or relapse within 3 months of discontinuation.
Immunosuppressants: azathioprine ≥ 2 mg/kg/day, 6-mercaptopurine (6-MP) ≥ 1.0 mg/kg/day (or therapeutic 6-thioguanine nucleotide [6-TGN] level) for ≥ 12 weeks, or methotrexate ≥ 15 mg/week subcutaneous or intramuscular.
Approved advanced therapies at the approved labelled dose:
Anti-tumor necrosis factor (TNF), anti-integrin (vedolizumab), or anti-IL-12/23 for at least 8 weeks; anti-IL 23 for at least 12 weeks.
Janus kinase (JAK) inhibitor for at least 8 weeks; sphingosine-1-phosphate receptor (S1PR) modulator for at least 12 weeks.
Note: Demonstration of intolerance requires no minimum dose nor duration of use.
Currently receiving one or more of the following treatments: i. Stable oral prednisone at ≤ 20 mg/day (or equivalent) or budesonide ≤ 9 mg for ≥ 2 weeks prior to randomization.
Stable dose of thiopurine (azathioprine or 6-MP) for ≥ 4 weeks prior to randomization, and have started the treatment ≥ 12 weeks prior to randomization.
Stable dose of oral aminosalicylates for ≥ 2 weeks prior to randomization.
Key Exclusion Criteria:• Diagnosis of Crohn's disease or IBD-Unclassified (IBD-U; indeterminate colitis) or a history of ischemic colitis or radiation colitis.
UC limited to rectum (< 15 cm from anal verge).
Any prior history of suicidal behavior (actual, interrupted, aborted attempt, or preparatory acts).
Columbia-Suicide Severity Rating Scale (C-SSRS) suicidal ideation type 4 or 5, or any active suicidal ideation with some intent to act.
Severe depression at Screening based on a validated scale threshold (e.g., Patient Health Questionnaire-9 [PHQ-9] ≥ 20, or PHQ-9 item 9 > 0) at Screening.
Failure or intolerance of > 3 classes of approved advanced therapies or > 4 approved individual advanced therapies.

Who cannot join

None listed.

Trial locations and contacts

115 sites in 12 countries. Contact the study team or a site near you to ask about taking part.

Country

City, postcode or hospital

Sites recruiting now only

115 sites in 12 countries

United States30 sites, 30 recruiting

Site US-002
Albany, New York, 12206
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Recruiting
Site US-008
Baton Rouge, Louisiana, 70809
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site US-021
Bellevue, Washington, 98004
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Recruiting
Site US-028
Bristol, Connecticut, 06010
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Recruiting
Site US-025
Brunswick, Ohio, 44212
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Recruiting
Site US-014
Clifton, New Jersey, 07013
ASCENTRA-UC, (858) 704-4900, ASCENTRA-UC@palisadebio.com
Recruiting
Site US-003
Cordova, Tennessee, 38018
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Recruiting
Site US-023
Dayton, Ohio, 45415
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Recruiting
Site US-005
Des Plaines, Illinois, 60016
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Recruiting
Site US-024
Garland, Texas, 75044
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Recruiting
Site US-009
Georgetown, Texas, 78628
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Recruiting
Site US-007
Glenview, Illinois, 60026
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Recruiting
Site US-020
Gurnee, Illinois, 60031
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Recruiting
Site US-030
Houston, Texas, 77024
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Recruiting
Site US-015
Lubbock, Texas, 79424
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Recruiting
Site US-011
Mandeville, Louisiana, 70471
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Recruiting
Site US-017
Mansfield, Texas, 760063
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Recruiting
Site US-012
Milwaukee, Wisconsin, 53215
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Recruiting
Site US-026
Orlando, Florida, 32825
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Recruiting
Site US-019
Providence, Rhode Island, 02905
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Recruiting
Site US-013
Richmond, Virginia, 23229
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Recruiting
Site US-016
Rochester, New York, 14618
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Recruiting
Site US-018
San Diego, California, 92103
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Recruiting
Site US-001
Southlake, Texas, 76092
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Recruiting
Site US-006
St Louis, Missouri, 63141
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Recruiting
Site US-022
Sun City, Arizona, 85351
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Recruiting
Site US-029
Tacoma, Washington, 98405
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Recruiting
Site US-010
Tupelo, Mississippi, 38801
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site US-004
Tyler, Texas, 75701
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Recruiting
Site US-027
Westlake, Ohio, 44145
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Recruiting

Other trials in United States

Poland22 sites, 22 recruiting

Site PL-014
Bydgoszcz, 85-794
ASCENTRA-UC, (858) 704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site PL-005
Elblag, 82-300
ASCENTRA-UC, (858) 704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site PL-006
Katowice, 40-748
ASCENTRA-UC, (858) 704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site PL-022
Kielce, 25-375
ASCENTRA-UC, (858) 704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site PL-020
Kłodzko, 57-300
ASCENTRA-UC, (858) 704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site PL-002
Krakow, 30-363
ASCENTRA-UC, (858) 704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site PL-016
Krakow, 31-228
ASCENTRA-UC, (858) 704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site PL-021
Lodz, 91-495
ASCENTRA-UC, (858) 704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site PL-004
Lublin, 20-582
ASCENTRA-UC, (858) 704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site PL-008
Nowy Targ, 34-400
ASCENTRA-UC, (858) 704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site PL-018
Opole, 45-819
ASCENTRA-UC, (858) 704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site PL-003
Poznan, 60-529
ASCENTRA-UC, (858) 704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site PL-010
Sopot, 81-756
ASCENTRA-UC, (858) 704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site PL-012
Staszów, 28-200
ASCENTRA-UC, (858) 704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site PL-001
Szczecin, 71-434
ASCENTRA-UC, (858) 704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site PL-015
Szczecin, 71-685
ASCENTRA-UC, (858) 704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site PL-007
Torun, 87-100
ASCENTRA-UC, (858) 704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site PL-019
Tychy, 43-100
ASCENTRA-UC, (858) 704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site PL-017
Warsaw, 00-189
ASCENTRA-UC, (858) 704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site PL-013
Warsaw, 04-501
ASCENTRA-UC, (858) 704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site PL-009
Wroclaw, 52-416
ASCENTRA-UC, (858) 704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site PL-011
Wroclaw, 53-611
ASCENTRA-UC, (858) 704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting

Other trials in Poland

Italy10 sites, 10 recruiting

Site IT-002
Bari, 70124
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site IT-004
Bologna, 40138
ASCENTRA-UC, (858) 704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site IT-007
Matera, 75100
ASCENTRA-UC, (858) 704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site IT-009
Negrar, 37024
ASCENTRA-UC, (858) 704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site IT-001
Rome, 00128
ASCENTRA-UC, (858) 704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site IT-003
Rome, 00133
ASCENTRA-UC ASCENTRA-UC, (858) 704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site IT-008
Rome, 00168
ASCENTRA-UC, (858) 704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site IT-006
Rozzano, 20089
ASCENTRA-UC, (858) 704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site IT-005
San Giovanni Rotondo, 71013
ASCENTRA-UC, (858) 704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site IT-010
Turin, 10126
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting

Other trials in Italy

Georgia8 sites, 8 recruiting

Site GE-003
Batumi, Quebec, 6010
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site GE-007
Tbilisi, Quebec, 0102
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site GE-002
Tbilisi, Quebec, 0144
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site GE-004
Tbilisi, Quebec, 0159
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site GE-008
Tbilisi, Quebec, 0160
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site GE-001
Tbilisi, Quebec, 0178
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site GE-005
Tbilisi, Quebec, 0180
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site GE-006
Tbilisi, Quebec, 0180
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting

Other trials in Georgia

Canada7 sites, 7 recruiting

Site CA-005
Calgary, Alberta, T2N 4L7
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site CA-004
Edmonton, Alberta, T6K 4E8
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site CA-006
Greater Sudbury, Ontario, P3C1X3
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site CA-003
London, Ontario, N6K 1M6
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site CA-007
Montreal, Quebec, H1T 2M4
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site CA-001
Montreal, Quebec, H2X 3E4
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site CA-002
Scarborough Village, Ontario, M1B3V4
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting

Other trials in Canada

Hungary7 sites, 7 recruiting

Site HU-005
Budapest, 1024
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site HU-002
Budapest, H-1062
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site HU-001
Budapest, H-1088
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site HU-004
Debrecen, H-4025
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site HU-007
Gyöngyös, H-3200
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site HU-006
Tatabánya, H-2800
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site HU-003
Veszprém, 8200
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting

Other trials in Hungary

Czechia6 sites, 6 recruiting

Site CZ-005
Brno, 602 00
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site CZ-002
Brno, 615 00
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site CZ-008
Havířov, 736 01
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site CZ-006
Hradec Králové, 500 12
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site CZ-007
Prague, 150 00
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site CZ-004
Slaný, 274 01
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting

Other trials in Czechia

Romania6 sites, 6 recruiting

Site RO-001
Bucharest, 020125
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site RO-003
Bucharest, 021967
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site RO-006
Constanța, 900663
ASCENTRA-UC, (858) 704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site RO-004
Ploieşti, 100032
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site RO-002
Timișoara, 300002
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site RO-005
Timișoara, 300239
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting

Other trials in Romania

Serbia6 sites, 6 recruiting

Site RS-006
Belgrade, 11 000
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site RS-001
Belgrade, 11 080
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site RS-002
Belgrade, 11000
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site RS-004
Leskovac, 16000
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site RS-005
Užice, 31000
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site RS-003
Zrenjanin, 23 000
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting

Other trials in Serbia

France5 sites, 5 recruiting

Site FR-003
Amiens, 80000
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site FR-005
Clermont-Ferrand, 63003
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site FR-002
Neuilly-sur-Seine, 92200
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site FR-001
Nice, 06200
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site FR-004
Saint-Priest-en-Jarez, 42270
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting

Other trials in France

Slovakia5 sites, 5 recruiting

Site SK-001
Banská Bystrica, 975 17
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site SK-004
Košice, 040 13
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site SK-002
Prešov, 080 01
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site SK-005
Prešov, 080 01
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site SK-006
Zvolen, 960 01
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting

Other trials in Slovakia

Latvia3 sites, 3 recruiting

Site LV-003
Liepāja, LV-3414
ASCENTRA-UC, (858) 704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site LV-002
Riga, LV-1002
ASCENTRA-UC, (858) 704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting
Site LV-001
Riga, LV-1012
ASCENTRA-UC, (858)704-4900, ASCENTRA-UC@palisadebio.com
Not yet recruiting

Other trials in Latvia

About this study

Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Induction and Maintenance Therapy With PALI-2108 in Participants With Moderately to Severely Active Ulcerative Colitis

Conditions: Ulcerative Colitis (UC), Severe Ulcerative Colitis, Moderate Ulcerative Colitis
Being tested: PALI-2108, Placebo
Keywords: Colitis, Ulcerative Colitis, Inflammatory Bowel Disease, IBD
Medical subject headings: Colitis, Ulcerative, Colitis, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PALI-2108Drug
Oral Dose
PALI-2108Drug
Oral Dose
PlaceboDrug
Oral Dose

Study groups in NCT07845487
Study group	Role	What they receive
PALI-2108 Dose 1	Experimental	15mg QD Receives: Drug: PALI-2108
PALI-2108 Dose 2	Experimental	30mg QD Receives: Drug: PALI-2108
Placebo	Placebo comparator	QD Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of participants with clinical remission using the 3-component modified Mayo Score (mMS) at Week 12.
The Modified Mayo Score (MMS) is a composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: Endoscopic subscore (ES), scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); Stool frequency subscore (SFS), scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and rectal bleeding subscore (RBS), scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.
Measured: Week 12

Secondary outcomes (6)

Proportion of participants with clinical response using 3-component mMS at Week 12.
The Modified Mayo Score (MMS) is a composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: Endoscopic subscore (ES), scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); Stool frequency subscore (SFS), scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and rectal bleeding subscore (RBS), scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.
Measured: At 12 weeks
Proportion of participants with endoscopic improvement at Week 12.
Endoscopic improvement is defined as Mayo endoscopic subscore (ES) of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.
Measured: Week 12
Proportion of participants with HEMI at Week 12.
HEMI is defined as a Geboes score of 3.1 or less and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration).
Measured: Week 12
Proportion of participants with clinical remission using the 3-component mMS at Week 48.
The Modified Mayo Score (MMS) is a composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: Endoscopic subscore (ES), scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); Stool frequency subscore (SFS), scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and rectal bleeding subscore (RBS), scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.
Measured: Week 48
Proportion of participants with endoscopic improvement at Week 48.
Endoscopic improvement is defined as Mayo endoscopic subscore (ES) of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.
Measured: Week 48
Proportion of participants with HEMI at Week 48
HEMI is defined as a Geboes score of 3.1 or less and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration).
Measured: Week48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Aug 2026Jun 2028

First posted29 Sep 2026
Study start28 Aug 2026
Primary completionOct 2027 (estimated)
Study completionJun 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 204 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07845487
Sponsor's protocol ID: PBI-2108-202
Acronym: ASCENTRA-UC
Status last verified: Sep 2026
First submitted: 21 Sep 2026
Last updated: 21 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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STOP-UC: De-escalation of Therapy in Patients With Ulcerative Colitis With Histological Remission
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All Ulcerative Colitis (UC) trials